LYRICA® (pregabalin) capsules CV is indicated for the management of Fibromyalgia.

Important Safety Information

LYRICA is contraindicated in patients with known hypersensitivity to pregabalin or any of its other components. Angioedema and hypersensitivity reactions have occurred in patients receiving pregabalin therapy.

There have been postmarketing reports of hypersensitivity in patients shortly after initiation of treatment with LYRICA. Adverse reactions included skin redness, blisters, hives, rash, dyspnea, and wheezing. Discontinue LYRICA immediately in patients with these symptoms.

There have been postmarketing reports of angioedema in patients during initial and chronic treatment with LYRICA. Specific symptoms included swelling of the face, mouth (tongue, lips, and gums), and neck (throat and larynx). There were reports of life-threatening angioedema with respiratory compromise requiring emergency treatment. Discontinue LYRICA immediately in patients with these symptoms.

Antiepileptic drugs (AEDs) including LYRICA increase the risk of suicidal thoughts or behavior in patients taking AEDs for any indication. Monitor patients treated with any AED for any indication for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Pooled analyses showed clinical trial patients taking an AED had approximately twice the risk of suicidal thoughts or behavior than placebo-treated patients. The estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one patient for every 530 patients treated with an AED.

Inform patients taking LYRICA that dizziness and somnolence may impair their ability to perform potentially hazardous tasks such as driving or operating complex machinery until they have sufficient experience with LYRICA to determine its effect on cognitive and motor function.

In controlled studies, a higher proportion of patients treated with LYRICA reported blurred vision (7%) than did patients treated with placebo (2%), which resolved in a majority of cases with continued dosing. Consider more frequent assessment for patients who are already routinely monitored for ocular conditions.

Higher frequency of weight gain and edema was observed in patients taking both LYRICA and thiazolidinedione antidiabetic drugs. Exercise caution when coadministering these drugs. Patients who are taking other drugs associated with angioedema such as angiotensin-converting enzyme inhibitors
(ACE inhibitors) may be at increased risk of developing angioedema. Exercise caution when using LYRICA in patients who have had a previous episode of angioedema.

Advise nursing mothers that breastfeeding is not recommended during treatment with LYRICA.

LYRICA may exacerbate the effects of oxycodone, lorazepam, or ethanol on cognitive and gross motor functioning.

Patients with a history of drug or alcohol abuse may have a higher chance of misuse or abuse of LYRICA.

Withdraw LYRICA gradually over a minimum of 1 week. Discontinue LYRICA immediately in patients with symptoms of hypersensitivity or angioedema.

Patients with a creatinine clearance of 30 to 60 mL/min had a greater incidence of discontinuation due to adverse reactions than patients with normal creatinine clearance. Adjust the daily dose of LYRICA for patients with reduced renal function (creatinine clearance ≤60 mL/min) and in those undergoing hemodialysis. Administer a supplemental dose of LYRICA immediately following every 4-hour hemodialysis treatment.

In standard, preclinical in vivo lifetime carcinogenicity studies of LYRICA, an unexpectedly high incidence of hemangiosarcoma was identified in 2 different strains of mice. The clinical significance of this finding is unknown. In clinical studies across various patient populations comprising 6396 patient-years of exposure in patients >12 years of age, new or worsening preexisting tumors were reported in 57 patients.

LYRICA® (pregabalin) capsules CV is indicated for the management of Fibromyalgia.

Important Safety Information

LYRICA is contraindicated in patients with known hypersensitivity to pregabalin or any of its other components. Angioedema and hypersensitivity reactions have occurred in patients receiving pregabalin therapy.

There have been postmarketing reports of hypersensitivity in patients shortly after initiation of treatment with LYRICA. Adverse reactions included skin redness, blisters, hives, rash, dyspnea, and wheezing. Discontinue LYRICA immediately in patients with these symptoms.

There have been postmarketing reports of angioedema in patients during initial and chronic treatment with LYRICA. Specific symptoms included swelling of the face, mouth (tongue, lips, and gums), and neck (throat and larynx). There were reports of life-threatening angioedema with respiratory compromise requiring emergency treatment. Discontinue LYRICA immediately in patients with these symptoms.

Antiepileptic drugs (AEDs) including LYRICA increase the risk of suicidal thoughts or behavior in patients taking AEDs for any indication. Monitor patients treated with any AED for any indication for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Pooled analyses showed clinical trial patients taking an AED had approximately twice the risk of suicidal thoughts or behavior than placebo-treated patients. The estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one patient for every 530 patients treated with an AED.

Inform patients taking LYRICA that dizziness and somnolence may impair their ability to perform potentially hazardous tasks such as driving or operating complex machinery until they have sufficient experience with LYRICA to determine its effect on cognitive and motor function.

In controlled studies, a higher proportion of patients treated with LYRICA reported blurred vision (7%) than did patients treated with placebo (2%), which resolved in a majority of cases with continued dosing. Consider more frequent assessment for patients who are already routinely monitored for ocular conditions.

Higher frequency of weight gain and edema was observed in patients taking both LYRICA and thiazolidinedione antidiabetic drugs. Exercise caution when coadministering these drugs. Patients who are taking other drugs associated with angioedema such as angiotensin-converting enzyme inhibitors
(ACE inhibitors) may be at increased risk of developing angioedema. Exercise caution when using LYRICA in patients who have had a previous episode of angioedema.

Advise nursing mothers that breastfeeding is not recommended during treatment with LYRICA.

LYRICA may exacerbate the effects of oxycodone, lorazepam, or ethanol on cognitive and gross motor functioning.

Patients with a history of drug or alcohol abuse may have a higher chance of misuse or abuse of LYRICA.

Withdraw LYRICA gradually over a minimum of 1 week. Discontinue LYRICA immediately in patients with symptoms of hypersensitivity or angioedema.

Patients with a creatinine clearance of 30 to 60 mL/min had a greater incidence of discontinuation due to adverse reactions than patients with normal creatinine clearance. Adjust the daily dose of LYRICA for patients with reduced renal function (creatinine clearance ≤60 mL/min) and in those undergoing hemodialysis. Administer a supplemental dose of LYRICA immediately following every 4-hour hemodialysis treatment.

In standard, preclinical in vivo lifetime carcinogenicity studies of LYRICA, an unexpectedly high incidence of hemangiosarcoma was identified in 2 different strains of mice. The clinical significance of this finding is unknown. In clinical studies across various patient populations comprising 6396 patient-years of exposure in patients >12 years of age, new or worsening preexisting tumors were reported in 57 patients.

WHAT IS FM MANAGEMENT?

FM.MGMT Online is a derivative of the FM.MGMT program, which was created to help
healthcare providers manage FM in the primary care setting.

The FM.MGMT program was based on the findings of the FibroCollaborative, an educational
initiative supported by Pfizer Inc. In 2010, the FibroCollaborative brought together
a faculty of 23 leading experts in FM management—including primary care practitioners
and specialists from the fields of rheumatology, pain management, neurology, and
psychiatry—to identify core principles and practical strategies for managing FM
in the primary care setting, where many FM patients first present and seek ongoing
care.

The practical resources provided in the
Resources section can facilitate efficient management of FM

The 4 core pillars of FM management

The 4 pillars that comprise the FM framework for primary care are general principles
that you are probably accustomed to applying to other chronic conditions (such as
asthma and diabetes) that you manage in your practice.

American college of Rheumatology (acr) Preliminary diagnostic criteria for fibromyalgia1

This is the American College of Rheumatology (ACR) preliminary diagnostic criteria
for Fibromyalgia. You or your office staff may administer this test to your FM patients to assess pain and symptom domains. Follow the instructions as given throughout, and the patient's scores will be calculated for you.

Patient Info

Patient First Name(optional)Patient Last Name(optional)‌Date(optional)‌‌

The information contained on this form was derived from Wolfe F, Clauw DJ, Fitzcharles M-A, et al. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res. 2010;62(5):600-610.

Privacy note: Information entered here is not saved or stored.

WIDESPREAD PAIN INDEX

Directions: Identify the areas where the patient felt pain over the past week by selecting the corresponding checkbox or body part.

LYRICA® (pregabalin) capsules CV is indicated for the management of Fibromyalgia.

Important Safety Information

LYRICA is contraindicated in patients with known hypersensitivity to pregabalin or any of its other components. Angioedema and hypersensitivity reactions have occurred in patients receiving pregabalin therapy.

There have been postmarketing reports of hypersensitivity in patients shortly after initiation of treatment with LYRICA. Adverse reactions included skin redness, blisters, hives, rash, dyspnea, and wheezing. Discontinue LYRICA immediately in patients with these symptoms.

There have been postmarketing reports of angioedema in patients during initial and chronic treatment with LYRICA. Specific symptoms included swelling of the face, mouth (tongue, lips, and gums), and neck (throat and larynx). There were reports of life-threatening angioedema with respiratory compromise requiring emergency treatment. Discontinue LYRICA immediately in patients with these symptoms.

Antiepileptic drugs (AEDs) including LYRICA increase the risk of suicidal thoughts or behavior in patients taking AEDs for any indication. Monitor patients treated with any AED for any indication for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Pooled analyses showed clinical trial patients taking an AED had approximately twice the risk of suicidal thoughts or behavior than placebo-treated patients. The estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one patient for every 530 patients treated with an AED.

Inform patients taking LYRICA that dizziness and somnolence may impair their ability to perform potentially hazardous tasks such as driving or operating complex machinery until they have sufficient experience with LYRICA to determine its effect on cognitive and motor function.

In controlled studies, a higher proportion of patients treated with LYRICA reported blurred vision (7%) than did patients treated with placebo (2%), which resolved in a majority of cases with continued dosing. Consider more frequent assessment for patients who are already routinely monitored for ocular conditions.

Higher frequency of weight gain and edema was observed in patients taking both LYRICA and thiazolidinedione antidiabetic drugs. Exercise caution when coadministering these drugs. Patients who are taking other drugs associated with angioedema such as angiotensin-converting enzyme inhibitors (ACE inhibitors) may be at increased risk of developing angioedema. Exercise caution when using LYRICA in patients who have had a previous episode of angioedema.

Advise nursing mothers that breastfeeding is not recommended during treatment with LYRICA.

LYRICA may exacerbate the effects of oxycodone, lorazepam, or ethanol on cognitive and gross motor functioning.

Patients with a history of drug or alcohol abuse may have a higher chance of misuse or abuse of LYRICA.

Withdraw LYRICA gradually over a minimum of 1 week. Discontinue LYRICA immediately in patients with symptoms of hypersensitivity or angioedema.

Patients with a creatinine clearance of 30 to 60 mL/min had a greater incidence of discontinuation due to adverse reactions than patients with normal creatinine clearance. Adjust the daily dose of LYRICA for patients with reduced renal function (creatinine clearance ≤60 mL/min) and in those undergoing hemodialysis. Administer a supplemental dose of LYRICA immediately following every 4-hour hemodialysis treatment.

In standard, preclinical in vivo lifetime carcinogenicity studies of LYRICA, an unexpectedly high incidence of hemangiosarcoma was identified in 2 different strains of mice. The clinical significance of this finding is unknown. In clinical studies across various patient populations comprising 6396 patient-years of exposure in patients >12 years of age, new or worsening preexisting tumors were reported in 57 patients.

Revised fibromyalgia impact questionnaire (FIQR)

This is the Revised FM Impact Questionnaire (FIQR). You may complete this
questionnaire with your patient or send it to the patient to fill out prior to
his or her visit to assess symptoms and functional status over the previous 7 days.
Follow the instructions as given, and the total FIQR score will be calculated for
you.

Patient Info

Patient First Name(optional)Patient Last Name(optional)‌Date(optional)‌‌

Privacy note: Information entered here is not saved or stored.

DOMAIN 1: FUNCTION

Directions: For each of the following 9 questions, select the box that best
indicates how much your Fibromyalgia made it difficult to perform each of the following
activities during the past 7 days. If you did not perform a particular activity
in the last 7 days, rate the difficulty for the last time you performed the activity.
If you can't perform the activity, check the last box.

Brush or comb your hair

No Difficulty

0
1
2
3
4
5
6
7
8
9
10

Very DIFFICULT

Walk continuously for 20 minutes

No Difficulty

0
1
2
3
4
5
6
7
8
9
10

Very 6DIFFICULT

Prepare a homemade meal

No Difficulty

0
1
2
3
4
5
6
7
8
9
10

Very DIFFICULT

Vacuum, scrub, or sweep floors

No Difficulty

0
1
2
3
4
5
6
7
8
9
10

Very DIFFICULT

Lift and carry a bag full of groceries

No Difficulty

0
1
2
3
4
5
6
7
8
9
10

Very DIFFICULT

Climb one flight of stairs

No Difficulty

0
1
2
3
4
5
6
7
8
9
10

Very DIFFICULT

Change bedsheets

No Difficulty

0
1
2
3
4
5
6
7
8
9
10

Very DIFFICULT

Sit in a chair for 45 minutes

No Difficulty

0
1
2
3
4
5
6
7
8
9
10

Very DIFFICULT

Shop for groceries

No Difficulty

0
1
2
3
4
5
6
7
8
9
10

Very DIFFICULT

DOMAIN 1: FUNCTION

DOMAIN 2: OVERALL

DOMAIN 3: SYMPTOMS

DOMAIN 2: OVERALL

Directions: For each of the following 2 questions, select the box that best
describes the overall impact of your Fibromyalgia over the last 7 days.

Fibromyalgia prevented me from accomplishing
goals for the week

Never

0
1
2
3
4
5
6
7
8
9
10

Always

I was completely overwhelmed by my
Fibromyalgia symptoms

Never

0
1
2
3
4
5
6
7
8
9
10

Always

DOMAIN 1: FUNCTION36

DOMAIN 2: OVERALL6

DOMAIN 3: SYMPTOMS

DOMAIN 3: SYMPTOMS

Directions: For each of the following 10 questions, select the box that best
indicates your intensity level of these common Fibromyalgia symptoms over the past
7 days.

LYRICA® (pregabalin) capsules CV is indicated for the management of Fibromyalgia.

Important Safety Information

LYRICA is contraindicated in patients with known hypersensitivity to pregabalin or any of its other components. Angioedema and hypersensitivity reactions have occurred in patients receiving pregabalin therapy.

There have been postmarketing reports of hypersensitivity in patients shortly after initiation of treatment with LYRICA. Adverse reactions included skin redness, blisters, hives, rash, dyspnea, and wheezing. Discontinue LYRICA immediately in patients with these symptoms.

There have been postmarketing reports of angioedema in patients during initial and chronic treatment with LYRICA. Specific symptoms included swelling of the face, mouth (tongue, lips, and gums), and neck (throat and larynx). There were reports of life-threatening angioedema with respiratory compromise requiring emergency treatment. Discontinue LYRICA immediately in patients with these symptoms.

Antiepileptic drugs (AEDs) including LYRICA increase the risk of suicidal thoughts or behavior in patients taking AEDs for any indication. Monitor patients treated with any AED for any indication for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Pooled analyses showed clinical trial patients taking an AED had approximately twice the risk of suicidal thoughts or behavior than placebo-treated patients. The estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one patient for every 530 patients treated with an AED.

Inform patients taking LYRICA that dizziness and somnolence may impair their ability to perform potentially hazardous tasks such as driving or operating complex machinery until they have sufficient experience with LYRICA to determine its effect on cognitive and motor function.

In controlled studies, a higher proportion of patients treated with LYRICA reported blurred vision (7%) than did patients treated with placebo (2%), which resolved in a majority of cases with continued dosing. Consider more frequent assessment for patients who are already routinely monitored for ocular conditions.

Higher frequency of weight gain and edema was observed in patients taking both LYRICA and thiazolidinedione antidiabetic drugs. Exercise caution when coadministering these drugs. Patients who are taking other drugs associated with angioedema such as angiotensin-converting enzyme inhibitors (ACE inhibitors) may be at increased risk of developing angioedema. Exercise caution when using LYRICA in patients who have had a previous episode of angioedema.

Advise nursing mothers that breastfeeding is not recommended during treatment with LYRICA.

LYRICA may exacerbate the effects of oxycodone, lorazepam, or ethanol on cognitive and gross motor functioning.

Patients with a history of drug or alcohol abuse may have a higher chance of misuse or abuse of LYRICA.

Withdraw LYRICA gradually over a minimum of 1 week. Discontinue LYRICA immediately in patients with symptoms of hypersensitivity or angioedema.

Patients with a creatinine clearance of 30 to 60 mL/min had a greater incidence of discontinuation due to adverse reactions than patients with normal creatinine clearance. Adjust the daily dose of LYRICA for patients with reduced renal function (creatinine clearance ≤60 mL/min) and in those undergoing hemodialysis. Administer a supplemental dose of LYRICA immediately following every 4-hour hemodialysis treatment.

In standard, preclinical in vivo lifetime carcinogenicity studies of LYRICA, an unexpectedly high incidence of hemangiosarcoma was identified in 2 different strains of mice. The clinical significance of this finding is unknown. In clinical studies across various patient populations comprising 6396 patient-years of exposure in patients >12 years of age, new or worsening preexisting tumors were reported in 57 patients.

This is the Modified Visual Analogue Scale of the Fibromyalgia Impact Questionnaire
(mVASFIQ). You may complete this questionnaire with your patient, or send
it to the patient to fill out prior to his or her visit. Follow the instructions
as given to quantify the severity of individual FM symptoms.

Patient Info

Patient First Name(optional)Patient Last Name(optional)‌Date(optional)‌‌

Privacy note: Information entered here is not saved or stored.

Directions: Please select the box that best indicates how you've felt overall
for the past week.

FATIGUE

How tired have you been?

No Tiredness

0
1
2
3
4
5
6
7
8
9
10

Very Tired

INSOMNIA

How have you felt when you got up in the morning?

Awoke Well Rested

0
1
2
3
4
5
6
7
8
9
10

Awoke Very Tired

BLUE

How depressed or blue have you felt?

Not Depressed

0
1
2
3
4
5
6
7
8
9
10

Very Depressed

How nervous or anxious have you felt?

Not Anxious

0
1
2
3
4
5
6
7
8
9
10

Very Anxious

Directions: Please select the box that best indicates how you've felt overall
for the past week.

RIGIDITY

How bad has your stiffness been?

No stiffness

0
1
2
3
4
5
6
7
8
9
10

Very stiff

OW!

How bad has your pain been?

No Pain

0
1
2
3
4
5
6
7
8
9
10

Very Painful

When you worked, how much did pain or other symptoms interfere with your ability
to do your work, including housework?

Scoring

LYRICA® (pregabalin) capsules CV is indicated for the management of Fibromyalgia.

Important Safety Information

LYRICA is contraindicated in patients with known hypersensitivity to pregabalin or any of its other components. Angioedema and hypersensitivity reactions have occurred in patients receiving pregabalin therapy.

There have been postmarketing reports of hypersensitivity in patients shortly after initiation of treatment with LYRICA. Adverse reactions included skin redness, blisters, hives, rash, dyspnea, and wheezing. Discontinue LYRICA immediately in patients with these symptoms.

There have been postmarketing reports of angioedema in patients during initial and chronic treatment with LYRICA. Specific symptoms included swelling of the face, mouth (tongue, lips, and gums), and neck (throat and larynx). There were reports of life-threatening angioedema with respiratory compromise requiring emergency treatment. Discontinue LYRICA immediately in patients with these symptoms.

Antiepileptic drugs (AEDs) including LYRICA increase the risk of suicidal thoughts or behavior in patients taking AEDs for any indication. Monitor patients treated with any AED for any indication for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Pooled analyses showed clinical trial patients taking an AED had approximately twice the risk of suicidal thoughts or behavior than placebo-treated patients. The estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one patient for every 530 patients treated with an AED.

Inform patients taking LYRICA that dizziness and somnolence may impair their ability to perform potentially hazardous tasks such as driving or operating complex machinery until they have sufficient experience with LYRICA to determine its effect on cognitive and motor function.

In controlled studies, a higher proportion of patients treated with LYRICA reported blurred vision (7%) than did patients treated with placebo (2%), which resolved in a majority of cases with continued dosing. Consider more frequent assessment for patients who are already routinely monitored for ocular conditions.

Higher frequency of weight gain and edema was observed in patients taking both LYRICA and thiazolidinedione antidiabetic drugs. Exercise caution when coadministering these drugs. Patients who are taking other drugs associated with angioedema such as angiotensin-converting enzyme inhibitors (ACE inhibitors) may be at increased risk of developing angioedema. Exercise caution when using LYRICA in patients who have had a previous episode of angioedema.

Advise nursing mothers that breastfeeding is not recommended during treatment with LYRICA.

LYRICA may exacerbate the effects of oxycodone, lorazepam, or ethanol on cognitive and gross motor functioning.

Patients with a history of drug or alcohol abuse may have a higher chance of misuse or abuse of LYRICA.

Withdraw LYRICA gradually over a minimum of 1 week. Discontinue LYRICA immediately in patients with symptoms of hypersensitivity or angioedema.

Patients with a creatinine clearance of 30 to 60 mL/min had a greater incidence of discontinuation due to adverse reactions than patients with normal creatinine clearance. Adjust the daily dose of LYRICA for patients with reduced renal function (creatinine clearance ≤60 mL/min) and in those undergoing hemodialysis. Administer a supplemental dose of LYRICA immediately following every 4-hour hemodialysis treatment.

In standard, preclinical in vivo lifetime carcinogenicity studies of LYRICA, an unexpectedly high incidence of hemangiosarcoma was identified in 2 different strains of mice. The clinical significance of this finding is unknown. In clinical studies across various patient populations comprising 6396 patient-years of exposure in patients >12 years of age, new or worsening preexisting tumors were reported in 57 patients.

Numeric Rating Scales for Symptoms and Functions in Fibromyalgia

for Symptoms and Functions in Fibromyalgia

These are the Numeric Rating Scales (NRS) for symptoms and function in FM.
You may complete this questionnaire with your patient or send it to the patient
to fill out prior to his or her visit. Follow the instructions as given to assess
symptom severity and functional impact.

Patient Info

Patient First Name(optional)Patient Last Name(optional)‌Date(optional)‌‌

Please note: These are examples of NRS. Others can be created to assess and follow
other specific symptoms or functional areas of concern for the individual patient.
These can be administered verbally or in writing.

Privacy note: Information entered here is not saved or stored.

PAIN

What number would you give your pain in the past week?

No Pain

0
1
2
3
4
5
6
7
8
9
10

Most Severe Pain you can possibly imagine

SLEEP

What number would you give your sleep in the past week?

No Sleep Problems

0
1
2
3
4
5
6
7
8
9
10

Worst sleep problems you can possibly
imagine

FATIGUE

What number would you give your fatigue in the past week?

No Fatigue

0
1
2
3
4
5
6
7
8
9
10

Most Severe Fatigue you can possibly imagine

EFFECT ON ABILITY TO WORK

What number would you give for the amount of impairment your Fibromyalgia has had
on work in the past week?

No Effect

0
1
2
3
4
5
6
7
8
9
10

Most severe effect on work you can
possibly imagine

EFFECT ON FAMILY CARE

What number would you give for the amount of impairment your Fibromyalgia has had
on family care in the past week?

No sleep problems

0
1
2
3
4
5
6
7
8
9
10

Most severe effect on family
care you can possibly imagine

EFFECT ON COGNITION ("Fibro Fog")

What number would you give for the amount of impairment your Fibromyalgia has had
on your ability to think clearly in the past week?

SCORING

LYRICA® (pregabalin) capsules CV is indicated for the management of Fibromyalgia.

Important Safety Information

LYRICA is contraindicated in patients with known hypersensitivity to pregabalin or any of its other components. Angioedema and hypersensitivity reactions have occurred in patients receiving pregabalin therapy.

There have been postmarketing reports of hypersensitivity in patients shortly after initiation of treatment with LYRICA. Adverse reactions included skin redness, blisters, hives, rash, dyspnea, and wheezing. Discontinue LYRICA immediately in patients with these symptoms.

There have been postmarketing reports of angioedema in patients during initial and chronic treatment with LYRICA. Specific symptoms included swelling of the face, mouth (tongue, lips, and gums), and neck (throat and larynx). There were reports of life-threatening angioedema with respiratory compromise requiring emergency treatment. Discontinue LYRICA immediately in patients with these symptoms.

Antiepileptic drugs (AEDs) including LYRICA increase the risk of suicidal thoughts or behavior in patients taking AEDs for any indication. Monitor patients treated with any AED for any indication for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Pooled analyses showed clinical trial patients taking an AED had approximately twice the risk of suicidal thoughts or behavior than placebo-treated patients. The estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one patient for every 530 patients treated with an AED.

Inform patients taking LYRICA that dizziness and somnolence may impair their ability to perform potentially hazardous tasks such as driving or operating complex machinery until they have sufficient experience with LYRICA to determine its effect on cognitive and motor function.

In controlled studies, a higher proportion of patients treated with LYRICA reported blurred vision (7%) than did patients treated with placebo (2%), which resolved in a majority of cases with continued dosing. Consider more frequent assessment for patients who are already routinely monitored for ocular conditions.

Higher frequency of weight gain and edema was observed in patients taking both LYRICA and thiazolidinedione antidiabetic drugs. Exercise caution when coadministering these drugs. Patients who are taking other drugs associated with angioedema such as angiotensin-converting enzyme inhibitors (ACE inhibitors) may be at increased risk of developing angioedema. Exercise caution when using LYRICA in patients who have had a previous episode of angioedema.

Advise nursing mothers that breastfeeding is not recommended during treatment with LYRICA.

LYRICA may exacerbate the effects of oxycodone, lorazepam, or ethanol on cognitive and gross motor functioning.

Patients with a history of drug or alcohol abuse may have a higher chance of misuse or abuse of LYRICA.

Withdraw LYRICA gradually over a minimum of 1 week. Discontinue LYRICA immediately in patients with symptoms of hypersensitivity or angioedema.

Patients with a creatinine clearance of 30 to 60 mL/min had a greater incidence of discontinuation due to adverse reactions than patients with normal creatinine clearance. Adjust the daily dose of LYRICA for patients with reduced renal function (creatinine clearance ≤60 mL/min) and in those undergoing hemodialysis. Administer a supplemental dose of LYRICA immediately following every 4-hour hemodialysis treatment.

In standard, preclinical in vivo lifetime carcinogenicity studies of LYRICA, an unexpectedly high incidence of hemangiosarcoma was identified in 2 different strains of mice. The clinical significance of this finding is unknown. In clinical studies across various patient populations comprising 6396 patient-years of exposure in patients >12 years of age, new or worsening preexisting tumors were reported in 57 patients.